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IRB Challenges for CTSA Sites

IRB Challenges for CTSA Sites. Challenge Areas. Multi-site Research Community Based Research Education and Preparation of ‘New’ Human Subjects Researchers Increased Use of Technology. Multi-site Research Challenges. Inconsistencies Resulting from Multiple IRB Reviews Changes in consent

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IRB Challenges for CTSA Sites

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  1. IRB Challenges for CTSA Sites

  2. Challenge Areas • Multi-site Research • Community Based Research • Education and Preparation of ‘New’ Human Subjects Researchers • Increased Use of Technology

  3. Multi-site Research Challenges • Inconsistencies Resulting from Multiple IRB Reviews • Changes in consent • Changes in design • CTSA structure emphasizes inter-institutional collaboration and data sharing

  4. Multi-site Research Challenges • Some Alternative Models not Recognized by VA HRPPs • NCI Central IRBs • Reviews under IRB authorization agreements • Particularly impacts sites with research centers in VA facilities (former GCRC sites)

  5. Multi-site Research Challenges • Reciprocity Agreement – UC Case Study • Agreement signed by all UC campuses and national labs • All FWAs amended • Applies to expedited review and exempt determination only

  6. Multi-site Research Challenges • UC Reciprocity Agreement Case Study • Coordination challenges among campuses • Who takes lead? • Requires central record repository • Challenge educating research community on new requirements • Issues with local non-IRB policies and committees • Conflict of Interest, radiation use, etc.

  7. Community Based Research • Community institutions have little or no human subjects research experience • Need FWA and policies • Need commitment to Belmont • Community researchers have few resources to conduct research • Clinical Research Coordinators • Time

  8. ‘New’ Human Subjects Researchers • Translational research involves new players not familiar with human subjects research requirements • Basic scientists • Clinical practitioners • Additional training and resources needed

  9. Technology Challenges • Increased use of technology to conduct research • Issues regarding data use and exchange • Research tasks performed automatically

  10. Thank you

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